Quality and Regulatory Affairs
Device Consulting:
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Preparation of regulatory submissions (510(k), PMA, IDE, CE Tech., Canadian PLA) to governmental health authorities; |
• Regulatory due diligence audits;
• Non-clinical laboratory test protocol development and management;
• Presentation before FDA advisory panels;
• Medical device software development and validation;v
• Engineering design development, verification and validation;
• GAP Audits of manufacturing facilities for conformance to:
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FDA Quality System / Good Manufacturing Practices (QS/GMP) regulations, |
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ISO 9000 [13485: 200X] Series Quality System Standards |
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Preparation of Standard Operating Procedures (SOP's) for manufacturing operations; |
• ETO Sterilization Validation.
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